Field of the Invention
The present invention relates generally to diagnostics and more specifically to a method and device for obtaining randomized tissue samples for statistical sampling and analysis for diagnostic and prognostic evaluations.
Background Information
Over the past several years, numerous genetic and epigenetic alterations were identified in a wide variety of disorders. In cancer, in particular, multiple alterations of etiologic and/or diagnostic values have been identified. Gene expression studies have identified single genes, or panels of genes to accurately diagnose normal, pre-malignant or malignant lesions, as well as to differentiate between subtypes of cancer. In addition to mRNA species, microRNA (miRNA) alterations have been determined to be associated with various inflammatory or malignant conditions, and can be used for diagnostic purposes. Epigenetic alterations have also been shown to be predictive of malignant transformation.
The diagnostic accuracy of various tests based on genetic or epigenetic alterations in particular, and histological analysis in general, is, however, intrinsically linked to the quality and volume of tissue that is available for analysis. As such, obtaining the relevant tissue is essential for the diagnosis.
Well executed tissue sampling procedures are especially crucial for biopsy of potential mucosal abnormalities in the gastrointestinal (GI) tract and elsewhere in the body that cannot be readily diagnosed based on their appearance on visual observation; e.g., during endoscopic examination. For example, several patchy conditions of the stomach, including infection with Helicobacter Pylori, autoimmune atrophic gastritis and dysplasia, mandate obtaining biopsies at several locations in the stomach. Similarly, biopsy-based diagnosis of microscopic colitis, dysplasia in ulcerative colitis, and others mandate obtaining multiple biopsies.
With the recent advent of endoscopy and laparoscopy, access to the inside of the human body has become routine. However, visual inspection is continually relied upon to aid diagnosis by obtaining tissue biopsy with tethered and relatively large biopsy forceps devices. Space limitations, time limitations and tissue damage limitations all contribute to dismal ability of performing a true statistical sampling of biologic tissue.
A key step to increase the number of biopsy sites while preventing unnecessary tissue damage is the miniaturization of the biopsy tools. Smaller tools are being developed for use at different biopsy sites to minimize tissue loss. However, they remain limited in application to the confined, low visibility environment of bodily passages.